The present invention relates to a method for labelling nebuliser ampoules manufactured using Blow Fill and Seal or Form Fill technology wherein the enclosed medicament is intended for delivery via the inhalation route.
Small molecules present in paper, adhesive and printing ink, such as the ink used in laser, inkjet or impact printing, can migrate through labels and polymer ampoule walls. This is a particular problem, for example, with nebulizer products made from low density polymers according to blow-fill-seal or form-fill-seal methods. The migration of these small molecules is considered a health and safety issue for nebulizer ampoules because the contents are medicaments intended for inhalation, and it is thought that components that migrate into the ampoule may incorporate potentially hazardous material into the medicament contained therein. Accordingly, for example, the United States Food and Drug Administration (US FDA) does not at present accept ink-based labelling for blow-fill-seal nebulizer ampoules intended for the inhalation route of administration.
However, there remains a need for alternative labelling of nebulized product ampoules. A current solution is to label nebulized product ampoules by embossing. However, embossing is an expensive and time consuming process. The process involves machining the moulding tooling with the desired labelling so that molten polymer can be drawn into the machined moulding inserts to leave the required embossed labelling on the surface of the product container. Each product needs a unique set of tooling and each time a different product requires manufacture, a different set of uniquely machined tooling needs to be fitted. Tooling is expensive and changing tooling on modern BFS machines causes extensive downtime.
As general background, JP 2006/220695 discloses a label for medical packaging comprising a protective layer of a colour different from a transparent print layer. WO2007/032900 describes a multi-layer laminate media, on which information may be applied in machine or human readable form using lasers or other high intensity light sources. US2004/0048172 describes a label film that can be inscribed using a laser beam. US2011/0256391 describes a layered material comprising polyvinylbutyral and an adhesive, wherein the polyvinylbutyral layer comprises irradiation-treated areas for use as a label.